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by Causes | 1.7.19

Note: This is a summary of a bill on the House schedule for Tuesday that doesn't yet have an ID. We'll transfer this summary to our normal bill page once an ID number is assigned.

What is it?

This bill would reauthorize programs under the Pandemic and All-Hazards Preparedness Reauthorization Act and amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. There are seven titles to this bill, each of which is summarized below.

Title I: Strengthening and Improving the National Health Security Strategy

This part of the bill would:

Clarify that the purpose of the National Health Security Strategy is to describe potential public health threats facing our nation and identify processes to prepare responses to such threats.
Incorporate three new items into the Strategy: 1) a description of the current public health workforce and its capabilities to improve medical surge capacity; 2) considerations for zoonotic disease and disease outbreaks related to food and agriculture; and 3) global health security and environmental hazards as they relate to domestic public health preparedness and response capabilities.

Title II: Improving Preparedness and Response

This part of the bill has six sections, each of which is summarized below:

\nSection 201: Improving Benchmarks and Standards for Preparedness and Response — This section would require the evaluation of existing performance measures, benchmarks, and standards for two core preparedness and response programs, the Public Health Emergency Preparedness (PHEP) cooperative agreement and the Hospital Preparedness Program (HPP).
\nSection 202: Amendments to Preparedness and Response Programs — Would clarify that the PHEP cooperative agreement should be administered through the Centers for Disease Control and Prevention (CDC) and update requirements for the plans required of all PHEP eligible entities. It’d also reauthorize the both the PHEP cooperative agreement and HPP through 2023.
\nSection 203: Regional Public Health Emergency Preparedness and Response Systems — This would charge the Assistant Secretary for Preparedness and Response (ASPR) with developing guidelines to inform regional hospital, health care facility, and public health facility systems of varying levels of capabilities to treat patients affected by chemical, biological, radiological, or nuclear (CBRN) threats, including emerging infectious diseases, and improving medical surge capabilities and capacity. It’d also use lessons learned from the 2014 Ebola virus outbreak to develop guidelines for regional systems to help provide a roadmap for regions agree the country to leverage their resources in the event of a bioterror attack, an emerging infectious disease outbreak, or a pandemic.
\nSection 204: Public Health Situational Awareness and Biosurveillance Capabilities — This section of the bill would direct the GAO to conduct a study on federal spending for CDC facilities and improved capabilities for responding to bioterrorism and other public health emergencies. It would also update and improve the CDC’s biosurveillance capabilities to advance public health situational awareness by increasing reporting of ongoing plans and holding additional public meetings with public & private stakeholders. Further, It’d would reauthorize biosurveillance programs through 2023.
\nSection 205: Strengthening and Supporting the Public Health Emergency Fund — This section of the bill would improve the existing Public Health Emergency Fund (PHEF) by identifying key authorities PHEF dollars can be used by in the immediate aftermath of, or lead up to, a public health emergency. It would also require the PHEF’s review by the Secretary and GAO, who’d be responsible for making recommendations to improve the program.
\nSection 206: Improving Preparedness and Response to All-Hazards by Public Health Emergency Volunteers — This part of the bill would encourage states to develop and implement programs and policies allowing the licensure of medical professionals to enable them to cross state lines during a public health emergency. It would also clarify that the National Disaster Medical System, Medical Reserve Corps members, and individual practitioners are eligible to enroll in the Emergency System for Advanced Registration of Volunteer Health Professionals (ESAR-VHP). It’d advise the Secretary to publicize the ways in which states are waiving licensing requirements for health professional volunteers during a public health emergency in order to encourage state and individual participation in ESAR-VHP. FInally, it’d reauthorize ESAR-VHP through 2023.

Title III: Reaching All Communities

This part of the bill has six sections, which are summarized below:

\nSection 301: Strengthening and Assessing the Emergency Response Workforce — This part of the bill recognizes that public health emergencies have strained the public health emergency workforce and highlighted gaps in workforce preparedness. To address these challenges, this section: 1) includes greater flexibility in pre-positioning response teams in advance of a public health emergency or potential public health emergency; 2) requires a joint review of the National Disaster Medical System (NDMS) and an assessment of America’s medical surge capacity; and 3) improves communication with Congress by requiring the Secretary to notify Congress when the NDMS workforce is insufficient to address a public health emergency. It would also reauthorize the NDMS and Medical Reserve Corps programs through 2023.
\nSection 302: Health System Infrastructure to Improve Preparedness and Response — This section encourages the ASPR to coordinate with public and private-sector partners that provide critical supplies or information to an affected area during a public health emergency, in order to assist with the response. It would also require the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to incorporate the need for certain medical supplies to be used with medical countermeasures (MCM) in MCM enterprise planning. Finally, it’d direct the Secretary to take manufacturing capacity and outside sources of medical supplies into account when replenishing products in the Strategic National Stockpile (SNS).
\nSection 303: Considerations for Al-Risk Individuals — This would update and align the term “at-risk individual” across the PAHPA framework to improve and ensure consistency in considerations and provide clarity throughout the framework.
\nSection 304: Improving Emergency Preparedness and Response Considerations for Children — This section would codify and continue the work of the CDC’s Children’s Preparedness Unit to ensure that children’s needs are taken into consideration when preparing for and responding to public health emergencies.
\nSection 305: Reauthorizing the National Advisory Committee on Children and Disasters — This section would update the Advisory Committee on children and disasters to incorporate additional non-federal stakeholders and reauthorize the Committee through 2023.
\nSection 306: Guidance for Participation in Exercises and Drills — Within two years, HHS would issue a final guidance on the ability of personnel funded by programs covered by this bill to participate in drills and exercises related to all-hazards medical and public health preparedness.

Title IV: Prioritizing a Threat-Based Approach

\nSection 401: Assistant Secretary for Preparedness and Response — This section would clarify the Congressional intent for the ASPR to utilize biodefense and emergency preparedness and response experience. It’d also encourage the ASPR to coordinate with the intelligence community and defense and public health agencies in their work to develop and strengthen America’s emergency preparedness and response framework.
\nSection 402: Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) — This section would codify the PHEMCE, an entity comprised of heads of relevant federal agencies, to inform the research, development, and procurement of MCMs for the SNS.
\nSection 403: Strategic National Stockpile — This section would provide additional direction and a threat-based focus for the existing annual review of the SNS. It’d also require additional information on SNS procurement and replenishment decisions, along with advanced planning for deployment, distribution, and dispensing for additions to the SNS. It would also charge the GAO with reviewing processes and decisions related to the SNS. FInally, it’d reauthorize the SNS through 2023.
\nSection 404: Preparing for Pandemic Influenza, Antimicrobial Resistance, and Other Significant Threats — This section would authorize the Director of the Biomedical Advanced Research and Development Authority (BARDA) to development strategic initiatives for threats posing a significant national security risk. These strategic initiatives would accelerate and support advanced R&D and procurement of countermeasures to address: 1) threats for which no countermeasure exists, or for which existing countermeasures may become ineffective; 2) threats that consistently exist or are continually circulating in a human or animal population and have significant potential to become a pandemic; and 3) certain threats related to CBRN agent exposure, which may present increased complications in treating a countermeasure resistant disease or condition during a public health emergency.
\nSection 405: Reporting on the Federal Select Agent Program — This section would require the Secretary to report on the implementation of recommendations from the Federal Experts Security Advisory Panel and the Fast Track Action Committee regarding improvements to the Select Agent Program.

Title V: Increasing Communication in MCM Research and Development

This title of the bill has four sections, which are summarized below:

\nSection 501: Medical Countermeasure Budget Plan — This section would update the Countermeasure Budget Plan to include considerations for manufacturing capabilities and capacity for MCMs, information on new and innovative technologies that may support MCM R&D, and improve the communication on areas of priority for MCM development.
\nSection 502: Material Threat and Medical Countermeasure Notifications — This section would require the HHS and DHS Secretaries to notify the relevant Senate and House committees of the material threat list on an annual basis, and to promptly notify Congress each time there’s a change to the threats on the list. It’d also require the Secretary to notify a MCM manufacturer as soon as possible regarding their decision to replenish such MCM in the SNS at the end of its contract.
\nSection 503: Availability of Regulatory Management Plans — This section would require the FDA to post the processes and information necessary for potential MCM sponsors to apply for a regulatory management plan on the internet, in order to raise awareness of the use of the plans for MCMs.
\nSection 504: BARDA and the Special Reserve Fund — This section would reauthorize BARDA and the BioShield Special Reserve Fund through 2023.

Title VI: Advancing Technologies for Medical Countermeasures

This title has three subsections, which are summarized below:

\nSection 601: Administration of Countermeasures — This section would clarify BARDA’s ability to use existing resources for developing technologies to assist in the administration of countermeasures.
\nSection 602: Medical Countermeasure Master Files — This would establish a clear process for submitting information and data on technologies into a Master File that may be incorporated into a future application to support a MCM product. It would also require the FDA to notify the Master File holder when the agency has referenced the technology in the Master File.
\nSection 603: Animal Rule Report — This would require the GAO to consult federal agencies, manufacturers, and other biodefense stakeholders to compile a report on the use of the animal rule in the development of MCMs. This report would be due within three years of this bill’s passage, and if applicable, it’d make recommendations to support and speed MCMs’ research and development.

Section VII: Reauthorizations and Technical Changes

This part of the bill would reauthorize funding for VA medical facilities and influenza vaccine tracking and distribution during an influenza pandemic. It’d also reauthorize the temporary reassignment authority through 2023.

Argument in Favor:

The threat posed by chemical, biological, radiological, or nuclear weapons (CBRNs) are only growing as America’s enemies seek new ways to attack its people. It’s important to fund federal programs that ensure health care professionals are trained and equipped to respond to these threats.

Argument Against:

Bioweapons don’t pose much of a credible threat to the U.S., and it’s irresponsible to spend billions of dollars preparing for a threat that’s unlikely to ever materialize. Rather than spending money on CBRN defense, it’d be better to ensure the U.S.’ conventional military capability is strong enough to deter these types of attacks.

Impact: HHS; DHS; National Health Security Strategy; GAO; Congress; HHS Secretary; DHS Secretary; PHEMCE; MCMs; hospitals; regional health systems; biomedical companies; CDC; PHEP; HPP; animal testing; BARDA; and the BioShield Special Reserve Fund.

Cost: The CBO estimated that the 2018 version of this bill would cost about $11.9 billion over the 2019-2023 period, assuming appropriation of the authorized amounts.

In-Depth: Reps. Anna Eshoo (D-CA) and Susan Brooks (R-IN) reintroduced this bill from the 115th Congress in order to reauthorize programs under the Pandemic and All-Hazards Preparedness Reauthorization Act. When this bill passed the House in 2018, Rep. Brooks said:

“It has been 17 years since anthrax attacks infected more than 17 people and ended five people’s lives. Since then, the threat of a chemical, biological, radiological, or nuclear incident has not dissipated, but instead continues to grow. Everyday our adversaries are looking for more effective and faster ways to produce a threat. I am proud this comprehensive bill ensures our health care professionals are trained to respond to possible pandemic outbreaks, prioritizes the further development of our national stockpile of vaccines, medical equipment and diagnostics, and establishes new advisory groups focused on protecting vulnerable populations such as senior citizens and people with disabilities during public health threats and emergencies. It reflects extensive feedback from the full range of medical and public health preparedness and response stakeholders in order to best examine our response as a nation to threats, and to ensure that moving forward, we have clear procedures, resources and support in place to keep Americans safe. PAHPA was first signed into law in 2006, and I am proud to lead this critically important reauthorization legislation.”

After this bill passed the House Energy and Commerce Committee in July 2018, the Biotechnology Innovation Organization (BIO) expressed its support:

“Over the past fifteen years, federal biodefense programs and agencies have spurred the creation of dozens of medical countermeasures, in partnership with industry, greatly improving our nation’s capacity to prepare and respond to the countless known and unknown chemical, biological, radiological and nuclear threats facing our nation. Yet with each passing week, the number and scale of these threats continues to grow – whether from rogue regimes, terrorist groups, emerging infectious diseases or pandemics. By authorizing increased, multi-year funding for these programs, as well as granting BARDA authority to address pandemic influenza, emerging infectious diseases, and antimicrobial resistance, this legislation would provide much needed flexibility and predictability for both government agencies as well as their private sector partners, which play a vital role in discovering and developing the medical countermeasures so desperately needed to protect our nation from these threats. Investments in preparedness and medical countermeasure development will enhance our response efforts, save lives, and be more cost effective in an emergency.”

Writing in the Bulletin of the Atomic Scientists in 2017, Filippa Lentzos, a senior research fellow jointly appointed in the Departments of War Studies and Global Health and Social Medicine and King’s College London, argued that biological weapons are an improbable choice for most U.S. adversaries, as terrorists are unlikely to get their hands on them and nations are constrained by the strong international norm against their use:

“At a stretch, terrorists taking advantage of advances in biology might be able to create a viable pathogen. That does not mean they could create a sophisticated biological weapon, and certainly not a weapon that could kill 30 million people. Terrorists in any event tend to be conservative. They use readily available weapons that have a proven track record—not unconventional weapons that are more difficult to develop and deploy. Available evidence shows that few terrorists have ever even contemplated using biological agents, and the extremely small number of bioterrorism incidents in the historical record shows that biological agents are difficult to use as weapons. The skills required to undertake even the most basic of bioterrorism attacks are more demanding than often assumed. These technical barriers are likely to persist in the near- and medium-term future… Where biological weapons are concerned, the focus should remain on national militaries and state-sponsored groups. These are the entities that might have the capability, now or in the near future, to develop dangerous biological weapons. The real threat is that sophisticated biological weapons will be used by state actors—or by financially, scientifically, and militarily well-resourced groups sponsored by states.”

However, Lentzos acknowledged, “in the near-to-medium term, however, advances in science and technology may enable the development of more capable and more accessible biological weapons” which “might allow attacks to be targeted more precisely.” This, “paired with changes in the social context around biological weapons… may lower barriers to the development and use of biological weapons.”

In the 115th Congress, this bill passed the House with the support of 24 bipartisan cosponsors, including 15 Democrats and nine Republicans. It also had the support of the Alliance for Biosecurity, American Academy of Pediatrics, American Hospital Association, and others.

Of Note: Congress mandated a dedicated effort to develop and stockpile drugs, vaccines and diagnostics to protect Americans from CBRN and pandemic threats after 9/11 and the 2001 anthrax attacks. In 2004, Congress passed the Project BioShield Act to create the Special Reserve Fund (SRF) and help fund the development of medical countermeasures against threats such as anthrax, Ebola, and plague.

The 2006 Pandemic and All-Hazards Preparedness Act created the position of ASPR to lead the government’s response to national health emergencies. It also created BARDA to provide industry partners with funding and technical assistance in the advanced R&D of medical countermeasures.

Media:

Summary by Lorelei Yang

(Photo Credit: iStockphoto.com / Obradovic)

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